RT Journal
A1 Mitka M
T1 SAfer devices bill
JF JAMA
JO JAMA
YR 2012
FD May 9
VO 307
IS 18
SP 1904
OP 1904
DO 10.1001/jama.2012.3896
UL http://dx.doi.org/10.1001/jama.2012.3896
AB
The bill would direct the FDA to issue a final Unique Device Identifier rule by the end of 2012, requiring every implantable device to carry a unique numerical identifier so products used in patients could be tracked through the distribution chain. The bill would also add medical devices to the Sentinel postmarketing surveillance initiative, which was launched in 2008 and monitors prescription drug safety after FDA approval.